MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-55-user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.Test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with tests results from meter to meter comparison of 54 mg/dl using truemetrix meter and 86 mg/dl using another device.Blood samples were taken from the same finger and customer was advised of proper testing technique.Wife stated customer had no symptoms of low blood sugar.Customer's expected fasting blood glucose test result range is 85 - 105 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2018, a back to back blood test was performed by the customer non-fasting and produced test results of 211 mg/dl and 221 mg/dl using truemetrix meter.The product is stored according to specification in the dining room; customer does travel in an rv camper and was advised of proper storage technique.The test strip lot manufacturer's expiration date is 08/16/2019 and open vial date is three days.The meter memory was reviewed for previous test result history: result 1 :80mg/dl date: (b)(6) 2018 time:5:32am fasting, result 2 :54mg/dl date: (b)(6) 2018 time:5:04am fasting, result 3 :84mg/dl date: (b)(6) 2018 time:6:13am fasting, result 4 :85mg/dl date: (b)(6) 2018 time:6:30am fasting, result 5 :92mg/dl date: (b)(6) 2018 time:6:35pm nfasting.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7975539
• Report Number: 1000113657-2018-01059
• Device Sequence Number: 201568
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• Combination Product (Y/N): N
• Initial Reporter State: MS
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/16/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1